QNCX - NASDAQ

Ladies and gentlemen, thank you for standing by, and welcome to the Cornerstone Therapeutics First Quarter 2013 Financial Results Call. [Operator Instructions] As a reminder, today's call is being recorded. With that said, I'll turn the call over to Amy Diebler of Cornerstone Therapeutics. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to Cornerstone Therapeutics conference call to discuss our first quarter 2013 results. We are glad to have you with us. I'm Amy Diebler, Senior Director of Corporate Finance and Development for Cornerstone Therapeutics. We are joined by Craig Collard, Cornerstone's Chief Executive Officer; and Alastair McEwan, Cornerstone's Chief Financial Officer. Craig will provide perspective on -- both on the quarter and on our 2013 outlook, and Alastair will cover the financial and operational results. Both Craig and Alastair will be available to answer your questions. Cornerstone issued a press release this morning containing financial results for the quarter ending March 31, 2013. Before we proceed with the call, please let me remind everyone that the following discussions and responses to your questions reflect management's view only as of today, May 9, 2013. Any statements about future expectations, plans and prospects, including without limitation, statements regarding our business strategy, future operations, financial position, anticipated regulatory approval of our products, possible therapeutic benefits, market acceptance, prospects and management's plans and objectives, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results and events may differ materially from those indicated by our forward-looking statements. Additional information about factors that could cause actual results or events to differ materially from those indicated by our forward-looking statements is included in the Safe Harbor statement in today's press release and in our filings with the Securities and Exchange Commission, including Item 1A to our annual report on Form 10-K filed on March 14, 2013, and in our subsequent Form 10-Q and other filings with the SEC. Cornerstone disclaims any obligation to update its forward-looking statements except as required by law. In addition, please note that Cornerstone's remarks contain supplementary non-GAAP financial measures, including non-GAAP income from operations, non-GAAP net income and non-GAAP net income per share diluted. A reconciliation of these measures to the comparable GAAP numbers is included in the press release, which is posted on our website. With that, I will now turn the call over to Craig.

Thank you, Amy, and good morning, everyone. Thank you for joining us on this call. Throughout 2012, we promised to become a real player in the specialty hospital market with multiple products, and in the first quarter of 2013, we experienced significant momentum from a strategic focus. This was a strong quarter for us as the increased sales of our key products and improved profitability demonstrate that with this strategy in place, we are well positioned for the future. The highlights from this quarter include net revenues reached $38 million, which is the highest quarterly revenue in the company's history and a testament to the strength of our products and everyone who's supporting them at Cornerstone. Gross margins increased 7 percentage points compared to the third quarter of 2012, primarily due to the addition of CARDENE to our product portfolio and improved margins on CUROSURF. We believe we will be able to maintain or continue to improve our gross margins that we experienced this quarter. Profitability greatly improved as net income per diluted share reached to $0.09, representing an increase of $0.16 per share compared to the first quarter of 2012. Our market products all continued to perform well and achieved continued growth. Let me give you a quick overview of each one. I'd like to start with CUROSURF, our market-leading natural lung surfactant for the treatment of Respiratory Distress Syndrome or RDS in premature infants. CUROSURF continues to be a strong product. And in the last quarter, we made strides to further improve product margins and our bottom line, which reflected in this quarter's results. We are encouraged to find that there are clear signs that the market climate of the past years is stabilizing, with total market volume for the past 6 months being roughly equal to that of the same period in the prior year. As a result, we anticipate that for the first time in several years, we will more fully recognize results from our efforts to grow market share and volume in 2013 and beyond. As in previous periods, we are largely focused on conversion of account, and we are pleased to report both a higher number of converted accounts and a higher total converted ML volume in the first quarter compared to the same quarter last year. Ultimately, I think it is fair to say that the integration of EKR, which resulted in a substantial increase in sales for size has resulted in enhanced account conversion and overall growth despite the expansion of the portfolio. Now moving to CARDENE. CARDENE is indicated for the short-term treatment of hypertension in the hospital market when oral therapy is not feasible or desirable. We acquired the worldwide rights to this product in June 2012 with the acquisition of EKR Therapeutics. And we are pleased with the positive impact it has had on our business, including our gross margins. CARDENE continues to perform well, especially when we review the average selling price, which continues to hold steady. Due to the superb efforts of our national account managers, we signed new agreements during the quarter with several key accounts. We also, as mentioned in the last call, continued to build our relationships with key opinion leaders and recently executed several key commercial activities, leveraging our expertise and guidance to drive CARDENE's educational efforts. Last,

Thanks, Craig, and good morning, everyone. As Craig said that we're very pleased with first quarter performance with strong top and bottom line growth. Revenue grew 71% year-over-year, bringing us to $38 million compared with $22.2 million in the first quarter of 2012. Looking at the market products that Craig mentioned, CUROSURF net product sales totaled $9.5 million, represent an increase of 25% compared to the first quarter of 2012. The rise in sales was driven by greater unit volume and decreases in chargebacks and price adjustments. This confirms CUROSURF's strong market performance and supports our ongoing confidence in that product. For the first quarter, CARDENE net sales were $13.8 million. As a reminder, this is the third quarter that we have marketed CARDENE as we acquired the product in June 2012 as part of the EKR transaction. We continue to be pleased with its performance, which is largely in line with our expectations at the time of the transaction. Lastly, net sales of

Thanks, Alastair. We will now take a look at what lies ahead. As we have said, in addition to our market products, we develop and maintain a promising pipeline and are working diligently to move these products forward to approval in commercial launch. Leveraging our commercial strength and all the know-how from growing the products already in our portfolio, we are confident in our prospect. I'd like to include a few additional updates regarding our pipeline. Let's start with our hydrocodone polistirex and chlorpheniramine polistirex extended release suspension, which is a generic equivalent of Tussionex used for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older. We are pleased with the significant progress of the manufacturing efforts in the most recent quarter and continue to look forward to entering the market for the upcoming 2013 cough and cold season. Moving to BETHKIS, which is a Tobramycin Inhalation Solution and is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. This is a very common condition in patients with CF, and nebulized tobramycin is considered the gold standard in treatment. This product is progressing as previously stated and remains on track to launch in Q3. Looking at RETAVASE, the quality of developmental efforts continue toward qualifying a new raw material supplier and transfer of certain aspects of the manufacturing process. We are making good progress on the FDA request from December 2012 and pending the outcome of certain investigational and schedule activities plan to initiate manufacture of new developmental batches this year. We remain positive on our ability to resolve the open issues. Expect to hear more detailed information from us on future calls, and we still anticipate the relaunch of RETAVASE in 2015. In parallel, using the current API RETAVASE, we plan to develop experimental batches and move forward our discussions with the FDA in regards to our catheter clearance program. We believe we can leverage key learnings from the current development program on RETAVASE to increase our probability of a success with catheter clearance. In regards to LIXAR, we continue to evaluate the viability of this investigational product candidate. Following the FDA's issuance of a complete response letter and request for additional clinical studies, we have committed to have a meeting with the FDA to discuss the path forward. The planning and statistical evaluation needed to support this meeting request is nearing completion. There remains our goal to request this meeting with the FDA very soon. As you can see by the financial and operational progress we've made in the first quarter of 2013, we feel more confident than ever that we have the right strategy in place to ensure that Cornerstone is well positioned for future growth. This morning, we announced the product deal with Digestive Care, Inc. to acquire exclusive U.S. rights to market the product PERT

[Operator Instructions] We'll take our first question from Matt Kaplan with Ladenburg Thalmann.

Can you give me a little bit more detail and thank you for the detail you provided on pancreatic lipase and the market in general. In terms of your strategy and how this really fits with BETHKIS and oh, in terms of the pancreatic enzyme market as well, are there -- is there one dominant player there, or how does that look in terms of the market share? And what type of market share do you think you guys can grab in the CF market and, I guess, in the GI market as well?

Yes. So to be clear, we will not be promoting the GI market. We only have rights for the CF market. So however, obviously with the focus that we have with BETHKIS, very rarely do you find a product that absolutely fits perfectly strategically. And where literally every call your representatives walk into, they can talk about both products that literally affect every patient that walks through that door. And that's what we have here. It's a perfect synergy and strategic fit. And in a market that's growing and in a market that's obviously gone from sort of DESI now to approved, which, obviously Cornerstone, is very familiar with, the dynamics of that market is, CREON, which is an avid product, obviously, is the market leader, and you've got VIMPAT and Pancrease. Those are so your 3 top products. And those 3, if you just base on IMS sales, you got a total market of around $650 million approximately. But between those 3, you're also approaching $550 million, $600 million. So they do really make the majority of the market share and, again, CREON being the leader. But one thing that we really like about PERT

Fair enough. And can you tell us a little bit about your -- the terms of your deal in terms of the licensing agreement? And what type of -- do you have to pay a royalty back, or how does that work in the structure in the agreement?

Yes. It just -- in sort of broad terms, we want to maintain similar margins to what we have or where we're going with the other products. So if you think about our margins being in the sort of 68% now, think about this product from a cost of good and a royalty that basically total roughly 30%. So we will be -- again, I've sort of stated before that we want to continue to improve those margins, and this product will fit within that. So that's, I guess, first and foremost. Secondly, as far as the deal structure, we did typical things where we give monies upfront, and then there's some monies based on milestones. It's sort of how this is laid out. The monies upfront will total roughly, depending on a few things that have to be done still with the product, will be roughly around $10 million, and that's sort of split between 2 payments, $2 million and $8 million. And then everything else is really milestone-based.

And what triggers the $8 million payment?

We're doing some things audit-wise, just with the suppliers and so forth, that will trigger that. So in a sense, we're -- that's kind of where we stand at this point.

And in aggregate, the milestone payments, are those sales-based? Or how does that work?

Yes, they're sales based. And where the -- I think the total payments, all in. Again, this is over a number of years, and milestones would -- could equate to around $30 million.

Up to the $39 million?

Yes.

Okay. Great. Now looks like a great addition to your portfolio in terms of the CF focus. Congratulations on that. And just going back to your currently marketed products,

Well, I guess, one, we're very happy with how

Okay. And now kind of a pipeline question, BETHKIS and planned launch in the third quarter. Does the agreement on PERT

Well, actually, PERT

The expiration of those co-promotes would add an additional $4 million per month?

Well that and the fact that, obviously, the product stay in a brand. I mean, there's a few things that have to happen. But it's important to note that it could be significant. Those 2 events could be really important.

Sure, sure. Great. And then just finally on the pipeline, RETAVASE, how is the progress going in terms of adjusting the manufacturing issue? And where are you on that?

Yes. No. it's going well. I mean, obviously, it's something we'd like to correct yesterday. But obviously, things take time. I will say that one of the things that we have as an internal goal that we, I think, we've also said a bit publicly is that we wanted to improve our regulatory structure, and we've hired a Head of Regulatory and Development, named Andreas Metpul [ph], whose actually in the room today. And we've also had -- hired another medical affairs person. And so we're trying to build structure within our group to really have more expertise and more folks internally to work on these things. So I think that's all moving in the right direction. But if things are really moving as planned with RETAVASE now -- I mean, we've obviously had the issue with stability. But again, I'll sort of go back to say I think this could have been a blessing in disguise in a lot of ways because had this happened post launch, it would've been a lot worse. So I think we're going to learn a few things here, and what may help us as well, we now have a group of folks who, consultant-wise, who have had some experience in this category that are helping us and, I think, are going to further the catheter clearance program as well. And so we're really getting ready to start moving that forward. We're hoping to have some FDA meetings later this year. And so I'm hoping these next few quarters, the updates we did -- I'm hoping to grab something substantial to talk about from that standpoint to be able to give data or at least where we are in the process. But so far, things are progressing nicely. And we think we've solved their issue.

Great. So if they progress on plan as you expect, when could you launch the catheter clearance clinical development?

I think if -- the only determining factor in that is we have a plan, if you will, that was fairly similar to what it'd done or have been done before with this type of trials. We believe that there's a possibility that we may be able to shorten some of that. So our timeframe currently is sort of a 2016 timeframe that we would launch that. We're hoping that if we can negotiate with the FDA based on some things that we've learned and reduce that trial time at all, then -- or the patient -- the number of patients and so forth, that may help us not only from the cost perspective but also a bit from the timing. But I think 2016 is a fair number.

Okay. So you could have some visibility to in terms of what's necessary with that program later this year?

Yes. That's what we're hoping, it's that we'll be able to say that we're kind of on track here and here's what we're going to have to do and that type of thing.

Great, great. And then 2 final questions. One, on business development, congrats on the PERT

Matt, you sound like my mother. It's like she's never satisfied with when I clean my room, she wants it cleaner. No. One, I think kudos to our business development folks. Joshua Franklin who leads that. We've continued to -- we constantly have deals flow in here, and I think one of the things we've continued to tell the market is that, look, we're a company that has proven that we can do this. So I think there may have been some questions considering the process that we're in, that things would stall and it wouldn't be business as usual. And I think this is a very good example that we're continuing to move forward, whether a deal happens or not, and looking at new things. So we're going to continue to do that. And I think the other point I would make is that we're building a substantial cash base in order to go fund more products. So I think the fact that cash is up over $63 million now also points to the fact that we're bringing new products, but we're also executing on our commercial business. And I think a lot of that obviously goes to what our reps do every day and so forth. So I mean, really, and think I said this last time, we couldn't be happier with where we sit now from a position standpoint. It's as strong as the company has ever been.

Yes. And I guess final question, the elephant in the room, so to speak. The Chiesi overture in terms of to acquire the remainder of the company, what's the timeline there, what's the process? Can you give us any kind of updates in terms of how that's going on with what's happening?

Well, I guess, the thing that I would say is, which -- I'm not involved in the process, so I don't -- other than what I've said before as far as there's negotiations going back and forth, that's really all I can say at this point. I'm not involved in it, and I'm really just not prepared to comment on this point because I just don't know.

[Operator Instructions] We'll hear next from Tim Lynch with Stonepine Capital.

I'll give it up a little more easily than Matt Kaplan did. I thought you just had a fantastic quarter and give you guys all the kudos for it, especially when a lot of companies are having tough Q1s with overstocking in Q4 and things like that. You guys really came through, and impressed that you're earning that dollar share run rate now on a non-GAAP basis. Couple of questions about PERT

Yes, sort of. So the Digestive Care is a great little company. They're private. And they were on the market before as a DESI product doing extremely well. But as you know, going through an NDA process like this because these were -- this wasn't a bile study. This was in a real -- it's the real-deal studies and unlike some of the DESI things that have happened in the past. But -- so it took quite a bit of money. And so I think they were at the point where they have commercialized this sort of a, let's call it a bit of a launch, just getting the product back out and going to some customers that had used the product in the past and that type of thing. And they have used some representatives that are sort of called the multiproduct reps but are not their reps internally. And so we viewed that as a real opportunity because, again, the product has a differentiation in the market. It's been there before, it's had existing sales. But we really felt like we could bring -- I think what DCI felt about is that we could really bring something special from a commercial standpoint just based on what we've done historically. So we really think this is going to be a great fit. Sort of we understand what these guys have went through. And we think what they want to do with us was let us grow this in the CF market. And I think they'll be looking to do other things maybe themselves in the GI market, which is a bigger market, but for us, it fits so well strategically. It just really made a lot of sense for both companies.

Okay. So kind of a limited launch in CF by the predecessor company. What -- is the DESI product -- was it removed prior to the spring of 2012 for the market? Or did it stay out of the market until this subsequent approval?

No, it was removed. This was very similar with what we went through in the cough cold situation. Once the FDA sort of put the gauntlet down, all products were removed. And I think the first one out was CREON. And obviously, if the market leader and then other subsequent approvals still after that. So PERT

Yes. And I know the market's changed then with all the NDAs. And I apologize if you mentioned this, but did you say what the predecessor product was doing in terms of revenue years ago before it was removed?

Yes. The last full year of sales in '09, the product was doing roughly $20 million. And again, so what sort of be happened in these situations, and that we've seen it time and time again where you've kind of had DESI products removed, new products come out, you see sort of a price increase in the market as a whole because now you've got fewer competitors that have gone through and actually spent monies to get approval. And I think that's exactly what happened here. So the only difference is PERT

And just in general, how much higher is the pricing in the market with actual NDAs drugs versus prior with the DESI product?

Roughly around 57%. So the total if you sort of took from then to now...

Okay. So for you guys to -- I know you've been off the market for a while. But to get this to $30 million or $40 million, is not that far from where it was prior, albeit in a different kind of environment with the -- with DESI products?

Yes. And the other thing too is without as many competitors, we see, as far as typical price increases and that type of thing, will be a little bit more normal, I guess, in this case. And also to -- from a category standpoint, reimbursement within this category is very good because the alternative is, if these patients don't get the therapy, you're looking at hospitalization and obviously more costs. So I think the ability to take your typical price increases per year are there, and so we continue to see the market going up, not only in volume because patients are living longer but also from the standpoint of pricing.

Great. And last question, I know you can't comment on discussions going on, but do you think the special committee will ever reach out to major shareholders or shareholders in general just to hear their opinions as part of this process? It's been about 2.5 months. As you know, we wrote a letter to the special committee, and we still have heard nothing even if it's just to hear our opinions on things in more detail.

Yes. Tim, at this point, I just -- I really don't know. I mean, I would think that, that would be something that probably happened at some point, and I guess it's just a timing thing. And again, I know it's difficult to be patient in this. And we're -- I'm in the same ballpark as you. I know nothing. And so it's very difficult for us because we've always been involved in everything, certainly me personally. So I would just add, be patient, and I think that hopefully, the committee will do their job, and we'll get to a decision either way.

Yes. And we're perfectly happy to be patient. We just hope that the special committee doesn't make the final decisions here in a vacuum with their advisors without speaking to the owner of the company a little bit. Not to relay information to us but just to hear our opinion, so that's just one comment that makes it.

[Operator Instructions] And we'll take our next question from Jason Aryeh with Jalaa Equities.

Just a follow-up on the strategic process. Is -- can you tell us, Craig, is the special committee and their advisors, are they looking at a broad strategic process? Or are they just looking at negotiations with Chiesi?

Again, that's probably even less than what I know, Jason. I just don't know. Sorry. I wish I could be more helpful there, but I just don't know.

But there's not a mandate for the special committee to open up the strategic process beyond Chiesi and let potentially all bidders in as products and companies with approved products seem to be more in favor than ever? I would think there would be a lot of strategic interest beyond simply Chiesi's, and we would hope that the special committee and their advisors would run a broad strategic process and allow all comers to bid on these assets, which I think would drive the highest price for shareholders.

No. Jason, I completely agree. Again, I just don't quite know what to say, so I don't -- I just don't know.

At this time, I show there are no further questions. I'd like to turn the call back over to Craig Collard for closing remarks.

We'd like to thank everyone today for joining the call and look forward to speaking to you next quarter.